Application 076945

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	TABLET;ORAL	10MG;12.5MG	No	No
002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	TABLET;ORAL	20MG;12.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL			2006-07-05
A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL			2006-07-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076945-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	2006-07-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076945-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	2006-07-05	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril Sodium and Hydrochlorothiazide	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	35019655-9a30-4305-a262-936ad0e73071	2024-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril Sodium and Hydrochlorothiazide
Fosinopril Sodium and Hydrochlorothiazide	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	CIPLA USA INC.	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2020-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril Sodium and Hydrochlorothiazide

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44328	ORIG	2006-07-17